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Archive for the 'Denosumab (AMG 162)' Category


Head to head data of Denosumab versus Fosamax Expected February 2008

Posted by drboneloss on October 22, 2007

NEW YORK, Sept 28 (Reuters) - Amgen Inc (AMGN.O: Quote, Profile, Research) said on Friday it expects to receive head-to-head data in February on its most important drug in development, denosumab, versus alendronate, which is sold by Merck & Co (MRK.N: Quote, Profile, Research) as Fosamax, for treating post-menopausal osteoporosis.

Amgen, the world’s largest biotechnical company, also said it expects to have Phase 3 post-menopausal osteoporosis fracture data in the second half of 2008, and is on target to review the entire post-menopausal osteoporosis data set in the second half of 2008.

The update on the development pipeline was given by Amgen’s executive vice president of Research and Development, at UBS Global Life Sciences Conference on Sept. 27. (Reporting by Ilaina Jonas)

Posted in Alendronate (Fosamax, Fosamax Plus D), Clinical Trials, Company News, Denosumab (AMG 162) | Tagged: , , , , , , , , , | No Comments »

Osteoporosisblogger picking up momentum with Wall Street and osteoporosis manufacturers

Posted by drboneloss on October 21, 2007

We are very pleased to see more and more companies and websites picking up on our articles.  Wall street journal and all of the osteoporosis drug makers come here and see what is happening in osteoporosis land.  A recent Wall Street Journal article links to our page which we are very grateful of. We hope to improve this website with more relevant content for you. Below is the article which references the job-cuts article on Novartis from October

Novartis, one of the leaders in the drug industry is shifting gears according to the article to maintain its strong position.  This is an early sign that might be followed by other pharma and biotech companies.  Since our blog pertains to osteoporosis treatment, we expect that some of the new therapies for osteoporosis could have difficulties getting approval. Pfizer is already delayed by more than 1 year for osteoporosis treatment with Oporia (a selective estrogen receptor modulator or SERM) and even received a non-approvable letter from the FDA much earlier.

We hope that new treatments will come through, both for all the patients out there as well as for the companies producing these high cost and high risk drug development programs. We are looking forward to Vivant, Denosumab and Odanacatib coming to the market place.  However, if a drug for a smaller company like Amgen will not get approval it will be much more devastating than for a large pharma company like Novartis, which is much more diversified, and who can get some of their revenue stream through the non-prescription business.

Novartis Shakes Ranks as Earnings Flag

Management Swap, Job Cuts Aim to Cope With Shifts in Market

By JEANNE WHALEN and GORAN MIJUK
October 19, 2007; Page A14

Novartis AG, long one of the drug industry’s best performers, is shifting gears in an effort to adjust to the tough regulatory and sales climate facing Big Pharma.

VASELLA’S PLAN

  Strategy Shift: Novartis revealed a management shake-up and U.S. job cuts, and said it will lean more heavily on its nonprescription-drug businesses.

  Regulatory Hurdles: The moves come as Novartis and others say new-drug approvals have become harder to gain.

  Tough Environment: The shift marks the challenges Big Pharma faces from generic drugs and other pressures.

The Swiss drug maker yesterday revealed a management shake-up, a revamp of its pharmaceutical division and job cuts in the U.S. after several setbacks led to poor third-quarter earnings. Novartis Chief Executive Daniel Vasella said the changes are designed to help the company in a time of more aggressive competition from generic drugs and stricter safety standards at the Food and Drug Administration. Among other measures, Novartis expects to lean more heavily on its nonprescription-drug businesses to drive sales growth, he said.

The shift was disclosed on the same day Pfizer Inc. said it would pull an inhaled-insulin product, leading to a sharp drop in its third-quarter results, underscoring the challenges facing the industry as a whole. Generic versions of branded drugs are providing tough competition in a time of renewed efforts to damp medical costs, and new blockbuster drugs have been hard to come by.

[Daniel Vasella]

Other drug makers yesterday affirmed the market and regulatory difficulties. Also yesterday, drug maker Wyeth posted a slightly lower third-quarter profit. “This is an environment that has become harder,” said Bernard Poussot, Wyeth’s incoming chief executive, referring to his immediate priority of overcoming the company’s recent troubles winning FDA approval for its drugs. “We have to find ways to get these products approved. I think we can make a big difference to patients, and therefore it is our job to adapt to the circumstances.”

Eli Lilly & Co. yesterday reported a 6% rise in third-quarter net income, as cost cuts and rising sales of newer products offset higher marketing and administrative expenses.

Novartis, of Basel, Switzerland, said the heads of its prescription-drug and consumer-health-care units are swapping jobs “to expand management experience and provide fresh impetus.”

Joe Jimenez, who joined the company in April as head of consumer health care, will take over the prescription-drug unit and carry out a reorganization aimed at simplifying decision making and pushing more medicines through to market, Novartis said. He also will oversee a cut of 1,260 jobs in the U.S. in an effort to save $230 million annually. Novartis will cut 750 jobs within the company and stop using 510 sales representatives from third parties.

[Ebeling Thomas]

Mr. Jimenez joined Novartis in April from Blackstone Group LP, the private-equity firm. He was previously on the board of AstraZeneca PLC and was an executive running H.J. Heinz Co.’s businesses in the U.S. and Europe.

The company said it also is establishing a unit called Novartis Biologics to focus more closely on developing biological medicines, an area big drug companies are rushing to master. Biological drugs make up 25% of the products in Novartis’s pipeline and “are increasingly a priority in R&D activities,” Novartis said.

Thomas Ebeling, who had run the prescription-drug business, will take over as head of consumer health care, which includes nonprescription drugs, medications for animals and contact lenses. The unit, along with the vaccines and diagnostics business and the generic-drug business, will become increasingly important to Novartis, Dr. Vasella said. “We want to accelerate the growth of the nonpharma businesses,” he told analysts on a conference call.

Several setbacks in the U.S. have tarnished the company’s performance. Sales of irritable-bowel-syndrome drug Zelnorm have plummeted 80% this year after the company withdrew the drug from the market in March at the request of the FDA, which was concerned about a possible link to angina, heart attacks and strokes. Several other drugs were hit by generic competition: Lamisil for nail-fungus infections, Lotrel for hypertension and Famvir for viral infections. Novartis also had expected to start selling the diabetes drug Galvus this year, but the FDA has declined to approve it.

The company said third-quarter net profit jumped to $6.87 billion from $1.87 billion a year earlier, helped by a $5.3 billion gain from the sale of its Gerber baby-food and medical-nutrition businesses to Nestlé SA. Excluding asset sales, profit fell 12% to $1.57 billion.

Overall sales rose by 9% to $9.61 billion, boosted by a gain from Novartis’s budding vaccine and diagnostics business and strong sales of drugs such as blood-pressure medication Diovan, leukemia medicine Gleevec and breast-cancer drug Femara.

Wyeth, of Madison, N.J., said sales of the company’s top-selling drug, the antidepressant Effexor, rose 4% to $958 million. Effexor is facing some generic competition for certain formulations. Sales for Wyeth’s second best-selling product, the pneumococcal vaccine Prevnar, increased 24% to $634 million.

[Novartis]

According to a note by analysts at Bear Stearns Cos., sales of Effexor were expected to come in at $937 million, while Prevnar sales were seen as hitting $652 million.

Wyeth posted net income of $1.15 billion, or 84 cents a share, weighed down by restructuring charges, compared with year-earlier profit of $1.16 billion, or 85 cents a share. Sales jumped 9% to $5.62 billion, but revenue from the blockbuster acid-reflux drug Protonix dropped 6% in part because of the possibility that a generic-drug maker might launch a version of that drug soon. Wyeth said it hasn’t seen any signs that such a launch has taken place thus far.

Lilly, of Indianapolis, raised its full-year earnings forecast. The company expects 2007 per-share pro-forma adjusted earnings of $3.50 to $3.55.

The company reported net income of $926.3 million, or 85 cents a share, compared with $873.6 million, or 80 cents a share, a year earlier. The latest results included a charge of six cents a share for insurance recoveries. Revenue rose 19% to $4.59 billion.

Sales of Lilly’s best seller, the antipsychotic Zyprexa, rose 8%, with U.S. sales up 4% and international sales gaining 11%. Its sales have been hurt recently by reports that it could trigger diabetes and unusual weight gain. Lilly expects modest growth in worldwide Zyprexa sales for 2007.

Lilly’s antidepressant Cymbalta had a sales jump of 47% to $513.2 million, as U.S. sales climbed 45% and international sales rose 64% mainly because of strong demand.

–Sarah Rubenstein, Val Brickates Kennedy and Mike Barris contributed to this article.

Write to Jeanne Whalen at jeanne.whalen@wsj.com and Goran Mijuk at goran.mijuk@dowjones.com

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•  U.S. Unlikely To Approve Novartis Drug

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Blog Posts About This Topic

•  J&J’s Drug Biz Struggles  blogs.wsj.com

•  Novartis cuts 1,260 U.S. jobs  osteoporosisblogger.com

Posted in Bazedoxifene (Aprela, Viviant), Company News, Denosumab (AMG 162), Market Strategies, Odanacatib MK0822 | Tagged: , , , , , , , , , , , , , , | No Comments »

Treatments for osteoporosis and bone diseases from cancer are similar

Posted by drboneloss on October 21, 2007

Advances in osteoporosis helps patients who suffer from metastases that have spread to the bone.  Pamidronate, an older and generic bisphosphonate for example, can be used to alleviate bone complications.  Other medications such as Zometa, which is now approved in the US and EU for osteoporosis as Reclast and Aclasta respectively also help with the disease.  Amgen’s denosumab could also be used for osteoporosis and bone metasatases if the phase III trials are succesful (results are expected in 3 to 4 years).  Here is an article describing the effects of bisphonates and denosumab on bone mestastases.

Dr. Mehta: Treating bone metastases

October 1, 2007

I saw Mrs. S in my office after she was found to have bone cancer. Bone cancer is a very loosely used term by patients and their families, but it has very specific implications when physicians deal with it. Cancer can start in the bones, which is called “primary” bone malignancy, but the more common scenario is when patient’s cancer spreads to the bones, referred to as “metastases.” In the case of Mrs. S, when she first developed chest pain, her initial approach was to use Motrin for pain relief for a couple of weeks. Unfortunately, her pain did not subside. After she had X-rays and CAT scans to evaluate her discomfort, her primary doctor told her that she had a spot in her sternum (the bone in front of the chest). Further tests revealed that Mrs. S had lung cancer and it had spread to her sternum. Cancer patients with bone metastases often have significant discomfort and pain requiring pain medications and specialized care. These patients can also develop fracture of bones. They often require “spot” radiation to alleviate the pain and discomfort. Cancers that spread to the bones include breast, lung, multiple myeloma, prostate cancer etc. Fracture of long bones is also not uncommon in patients who have bone metastases. Treatment for patients with bone metastases includes pain medications, radiation therapy, chemotherapy, and bisphosphonates. Medications like Aredia or Zometa (bisphosphonates) are routinely utilized on a once-a-month basis to alleviate bone pain in patients. A new drug, Denosumab, is being studied and directly compared to a bisphosphonate-zoledronic acid (Zometa) in a group of cancer patients with bone metastases. We offer this clinical trial from Amgen to patients at our office, and we have enrolled over a dozen patients. Results of this trial will be available in the next three to four years. Osteoporosis is also a major public health threat affecting nearly 44 million Americans. Osteoporosis is not a cancerous condition but it is a process of aging when there is decreased bone mineral density. Osteoporosis should not be confused with bone metastases. Osteoporosis affects women as well as men. Several prevention and treatment strategies for osteoporosis are already in place for post-menopausal women and I would urge my readers to discuss this with their doctors. Intravenous Bisphosphonate therapy given once a year also was approved for osteoporosis in post-menopausal women. This osteoporos drug, zoledronic acid (Reclast, a new drug which has the same ingredient as Zometa) was found to have the potential to cut the risk of spine fractures by 70 percent and the chance of hip fractures by 41 percent. Reclast can cause an abnormal heart rhythm (atrial fibrillation) as a rare side effect. It is interesting to note that physicians will be using the same drug (zoledronic acid — Zometa and Reclast) for patients who have osteoporosis and bone metastases, albeit on different schedules — once a year for osteoporosis and once a month for cancer patients with bone metastases. With advances in medical therapy, doctors are finding new treatments for osteoporosis. Oncologists are also better equipped to handle patients with bone metastases. A lot of positive research is being done in bone health, osteoporosis, bone metastases and the future of these research endeavors is very bright. Dr. Nilesh D. Mehta is clinical associate professor at Rosalind Franklin University. Source: http://www.suburbanchicagonews.com/newssun/lifestyles/582102,5_5_WA01_MEHTA_S1.article

Posted in Clinical Trials, Denosumab (AMG 162), Pamidronate (Aredia), Zoledronic acid (Reclast, Aclasta, Zometa) | Tagged: , , , , , , , , , , , , , , , | No Comments »

Recruiting Phase III clinical trial with Amgen, Denosumab (AMG 162)

Posted by Dr.Osteo on October 12, 2007

Amgen http://www.osteoporosisblogge

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Amgen homepage

Denosumab (AMG 162) http://www.osteoporosisblogge

Denosumab is a fully human monoclonal antibody that specifically targets the receptor activator of nuclear factor kappa B ligand (RANKL), a key mediator of the resorptive phase of bone remodeling. Denosumab is being studied across a range of conditions, including osteoporosis, treatment-induced bone loss, rheumatoid arthritis, bone metastases, and multiple myeloma. Source

Mechanism of Action http://www.osteoporosisblogge

Receptor activator of nuclear factor-kappaB ligand (RANKL) is essential for osteoclast differentiation, activation and survival. Recently, denosumab, a human monoclonal antibody to RANKL, has been tested in the treatment of osteoporosis. But the interactions between RANKL, receptor activator of nuclear factor-kappaB (RANK) and osteoprotegerin (OPG) are also involved in immune regulations in addition to bone metabolism. So, blocking RANKL could interplay with immune cells and have systemic effects. Source

Recruiting Clinical trials http://www.osteoporosisblogge

Phase III Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis

Purpose

This is a 2 year multi-national, multi-center, open-label, single-arm extension study enrolling subjects who have completed the 3 year pivotal study. for additional info click here


Not yet recruiting…

Denosumab Adherence Preference Satisfaction Study

Purpose

The primary objective is to evaluate the adherence of subjects to SC 60 mg denosumab Q6M treatment compared to oral 70 mg alendronate QW treatment at the end of treatment period 1 (12 months). for additional info click here

 

Clinical trials with other drugs

- Recruiting Phase III Clinical Study With MK0822 (odanacatib) in Postmenopausal Women With Osteoporosis to Assess Fracture Risk Reduction

- Recruiting osteoporosis clinical trials with Ibandronic acid/Ibandronate (Boniva) as of Oct. 08

- Recruiting osteoporosis clinical trials with Zoledronic Acid (Reclast) - As of Oct. 04 2007

Posted in Clinical Trials, Denosumab (AMG 162) | Tagged: , , , , , , , , , , , , , , , | No Comments »